Introduction; Customer Service; Indications; Contraindications - On-X ONXI2 Modo De Empleo

INTRODUCTION

This booklet is intended to aid the clinician by providing instructions for the handling and
use of the ON-X LTI On-X
The instruments are comprised of sizers, rotators, instrument handle(s), and a leaflet
motion probe(s). Upon receipt, if any instrument is damaged, DO NOT USE. Call ON-X LTI
Customer Service to arrange for a replacement.

CUSTOMER SERVICE

ON-X LTI Customer Service representatives can be reached at (888) 339-8039 (USA and
Canada only), (512) 339-8039 or email address ONX@ONXLTI.COM

INDICATIONS

The Instruments are intended to be used to facilitate the implantation of On-X
Heart Valves.

CONTRAINDICATIONS

The Instruments should not be used for any purpose other than the implantation of On-X
Prosthetic Heart Valves.

DESCRIPTION AND FUNCTIONS OF THE INSTRUMENTS

The instrument kit contains a sizer and a rotator for each size of the On-X
Heart Valve. Aortic replica sizers are included for size 19 through 27/29 mm aortic valves.
A universal instrument handle and leaflet probe are also included. The instruments are
reusable.
Sizers – The sizers are used to gauge the resulting tissue annulus diameter after the annulus
is prepared for implant. The sizers are designed to be used for both aortic and mitral valve
sizing and include size designations. The sizers are cylindrical for size 19 through 25 mm
valves (Figure 1A) and conical for size 27/29 and 31/33 mm valves (Figure 1B). To facilitate
sizer selection, refer to Table 1.
The sizer has a bendable stem on each end.
Repeated bending of the stems may cause
metal fatigue. The effects of metal fatigue
can be seen by the user in the form of
readily apparent surface cracks on the stem.
To avoid instrument fracture during use, the
stem should be inspected for surface cracks
before and after each time it is bent. If metal
fatigue surface cracks are present, the sizer
should be discarded and replaced. Contact
ON-X LTI Customer Service to receive
replacement sizers.
Aortic Replica Sizers – The aortic replica
sizer (Figure 1A) models the On-X
valve profile. It is used after sizing to assure
fit of the aortic valve without obstruction of
the coronary arteries. Aortic replica sizers
are provided for size 19 through 25 mm
aortic valves, where the valve sewing cuff is
intended to remain supra-annular. The size
27/29 mm aortic valve is an intra-annular
design and its replica sizer is designed to
model this positioning.
2
®
Prosthetic Heart Valve Instruments (Ref: ONX I 2 and ONXI3).
®
aortic
Cylindrical
Figure 1A
Conical
Figure 1B
ON-X LTI INsTrumeNT IFu - eNGLIsH
®
Prosthetic
®
Prosthetic
Aortic Replica
®